Nonrandomized Phase II Hybrid Type 3 Implementation Study: Feasibility and Acceptance of an EHR-embedded Oral Cancer Directed Therapy Toxicity and Adherence Program for Patients With Breast or Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ePRO Oral Response Rate
研究概览
简要总结
This is research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (Oral Cancer Directed Therapy). This study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and integrate toxicity/adherence reporting.
详细描述
For patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
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Participants will complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice
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Participants between clinic visits, will be asked to complete the oral weekly survey at home via the mobile or web based patient portal. The survey can be completed on a computer, tablet or smartphone at home or on a tablet at the time of scheduled visit.
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The first 100 participants to complete the survey will receive a passive care team alert for responses (per DFHCC policy)
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The second 100 participants to complete the survey will receive an active care team alert for responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age 18 or older
- •Male or Female
- •Scheduled visit at DF/HCC within the BOC or GCC
- •Diagnosis of advanced breast cancer or gastrointestinal cancer
- •Prescribed any OCDT within prior 5 days of screening
- •English as the primary language (as documented in the EHR, written or spoken, and patient interpreter needed flag = no)
- •Mobile number listed in EHR to allow participation in ePP portion of the study
- •Women of any pregnancy status
- •Patients diagnosed with an advanced cancer will be eligible to participate in the study until discontinuation of OCDT or death, whichever occurs first
排除标准
- •Adults unable to provide verbal consent
- •Pediatric patients
- •Patients without access to a electronic device (including tablet, computer, aptop or smartphone)
研究组 & 干预措施
Passive Care Team Alert
DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
- Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice
- ePRO Home: -- ePRO oral between visits at home.
- Passive care team alert -- EHR inBasket notification
干预措施: Passive Care Team Alert (Other)
Active Care Team Alert
DFCI patients with advanced breast or gastrointestinal cancer prescribed Oral Cancer Directed Therapy.
- Screening: ePRO Clinic:-- complete ePRO clinic for all medical oncology scheduled provider appointments during the study period per standard practice
- ePRO Home: -- ePRO oral between visits at home.
- Active care team alert -- practice nurse monitoring of ePRO home responses score = 3 indicating a moderate-severe toxicity (grade 3 or higher
干预措施: Active Care Team Alert (Other)
结局指标
主要结局
ePRO Oral Response Rate
时间窗: 30 days
proportion of participants responding to at least 50% of ePRO oral questionnaires at 30 days
次要结局
- ePRO Oral Response Rate(90 days)
- Average number of ePRO oral questionnaires completed per week(90 Days)
- ePRO oral ease of use(90 Days)
- Proportion of Participants with an ePRO Intervention(90 Days)
- Proportion of Participants reporting ePRO grade 3+ toxicity(90 Days)
- Participant Report of OCDT Frequency(30 Days)
- ePRO oral willingness(90 Days)
- ePRO Oral Response Rate(60 days)
- Participant Report of OCDT Frequency(90 Days)
研究者
Nadine McCleary MD, MPH
Principal Investigator
Dana-Farber Cancer Institute